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Last Updated: January 27, 2020

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LAMOTRIGINE Drug Profile

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When do Lamotrigine patents expire, and when can generic versions of Lamotrigine launch?

Lamotrigine is a drug marketed by Alembic Pharms Ltd, Aurobindo Pharma, Dr Reddys Labs Ltd, Glenmark Pharms Ltd, Jubilant Generics, Mylan, Sandoz, Taro, Teva, Watson Labs, Zydus Pharms Usa Inc, Actavis Elizabeth, Amneal Pharms, Anchen Pharms, Par Pharm, Rubicon, Torrent, Wockhardt Ltd, Impax Labs Inc, Sciegen Pharms Inc, Actavis Totowa, Alkem Labs Ltd, Celltrion, Cipla, Glenmark Generics, Hikma Pharms, Jubilant Cadista, Lupin Ltd, Mylan Labs Ltd, Pharmascience Inc, Roxane, Taro Pharm Inds, Torrent Pharms, Unichem Labs Ltd, and Zydus Pharms Usa. and is included in forty-six NDAs.

The generic ingredient in LAMOTRIGINE is lamotrigine. There are thirty-two drug master file entries for this compound. Fifty suppliers are listed for this compound. Additional details are available on the lamotrigine profile page.

US ANDA Litigation and Generic Entry Outlook for Lamotrigine

A generic version of LAMOTRIGINE was approved as lamotrigine by DR REDDYS LABS LTD on January 27th, 2020.

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Drug patent expirations by year for LAMOTRIGINE
Drug Prices for LAMOTRIGINE

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Drug Sales Revenue Trends for LAMOTRIGINE

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Recent Clinical Trials for LAMOTRIGINE

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SponsorPhase
Charite University, Berlin, GermanyN/A
Boehringer IngelheimN/A
Agios Pharmaceuticals, Inc.Phase 1

See all LAMOTRIGINE clinical trials

Recent Litigation for LAMOTRIGINE

Identify potential future generic entrants

District Court Litigation
Case NameDate
Glaxo Group Ltd. v. Aurobindo Pharma USA, Inc.2017-12-27
PAR PHARMACEUTICAL, INC. v. GLAXOSMITHKLINE LLC2014-11-19
Janssen Pharmaceutica N V v. Mylan Pharmaceuticals Inc.2005-06-07

See all LAMOTRIGINE litigation

Synonyms for LAMOTRIGINE
1,2,4-Triazine-3,5-diamine, 6-(2,3-dichlorophenyl)-
3,5-diamino-(2,3-dichlorophenyl)-1,2,4-triazine
3,5-diamino-6-(2,3-dichlorophenyl)- as -triazine
3,5-Diamino-6-(2,3-dichlorophenyl)-1,2,4-triazine
3,5-Diamino-6-(2,3-dichlorophenyl)-as-triazine
3,5-diamino-6-(2,3,-dichlorophenyl)-1,2,4-triazine
57L841
6-(2,2,4-triazine-3,5-diyldiamine
6-(2,3-Dichloro-phenyl)-[1,2,4]triazine-3,5-diamine
6-(2,3-Dichloro-phenyl)-[1,2,4]triazine-3,5-diamine(lamotrigine)
6-(2,3-Dichlorophenyl)-1,2,4-triazine-3,5-diamine
6-(2,3-dichlorophenyl)-1,2,4-triazine-3,5-diamine.
6-[2,3-bis(chloranyl)phenyl]-1,2,4-triazine-3,5-diamine
84057-84-1
A840709
AB0014255
AB00384359_17
AB00384359_18
AB00384359-16
AC-10298
AC1L1GWT
AJ-08354
AKOS005561147
AN-35947
ANW-44921
AT-15488
B2249
BC200572
BCP12156
BDBM50031299
BIDD:GT0794
BR-72807
BRD-K93460210-071-01-6
BW 430C
BW-430C
BW430C
C9H7Cl2N5
CAS-84057-84-1
CCG-100856
CHEBI:6367
CHEMBL741
CPD000058464
CS-2616
CTK8B4406
D00354
DB00555
DSSTox_CID_3195
DSSTox_GSID_23195
DSSTox_RID_76918
DTXSID2023195
EINECS 281-901-8
EU-0100688
EUR-1048
F2173-0540
FT-0602546
GI 267119X
GI 267119X; 6-(2,3-dichlorophenyl)-1,2,4-triazine-3,5-diamine
GTPL2622
GW 273293
HMS2051C10
HMS2089M08
HMS2093P21
HMS2230L04
HMS3262I17
HMS3268G17
HMS3371O16
HMS3393C10
HMS3657A17
HMS3715H21
HSDB 7526
HY-B0495
hydroxymethyl progesterone
J10032
K499
KS-00000XIV
KS-1074
L 3791
L-205
L0241
Labileno
Lamictal
Lamictal (TN)
Lamictal Cd
Lamictal ODT
Lamictal XR
Lamictin
Lamiktal
Lamitor
Lamotrigina
Lamotrigina [Spanish]
Lamotrigine (JAN/USAN/INN)
Lamotrigine [USAN:INN:BAN]
Lamotrigine [USAN:USP:INN:BAN]
Lamotrigine 1.0 mg/ml in Methanol
Lamotrigine for peak identification, European Pharmacopoeia (EP) Reference Standard
Lamotrigine for system suitability, European Pharmacopoeia (EP) Reference Standard
Lamotrigine solution, 1.0 mg/mL in methanol, ampule of 1 mL, certified reference material
Lamotrigine, >=98%, powder
Lamotrigine, 98%
Lamotrigine, British Pharmacopoeia (BP) Reference Standard
Lamotrigine, European Pharmacopoeia (EP) Reference Standard
Lamotrigine, Pharmaceutical Secondary Standard; Certified Reference Material
Lamotrigine, United States Pharmacopeia (USP) Reference Standard
Lamotriginum
Lamotriginum [Latin]
Lopac-L-3791
Lopac0_000688
LP00688
LS-155249
MCULE-7648410888
MFCD00865333
MLS000069685
MLS000759486
MLS001077325
MLS001423991
MolPort-003-666-744
NC00106
NCGC00015605-01
NCGC00015605-02
NCGC00015605-03
NCGC00015605-04
NCGC00015605-05
NCGC00015605-06
NCGC00015605-07
NCGC00015605-08
NCGC00015605-09
NCGC00015605-10
NCGC00022936-02
NCGC00022936-04
NCGC00022936-05
NCGC00261373-01
NE61394
NSC-746307
NSC-759171
NSC746307
NSC759171
Opera_ID_12
Pharmakon1600-01505610
PYZRQGJRPPTADH-UHFFFAOYSA-N
Q-201221
s3024
SAM001246697
SBI-0050666.P002
SC-12025
SCHEMBL35439
SMP2_000303
SMR000058464
SR-01000000187
SR-01000000187-10
SR-01000000187-2
SR-01000000187-4
SR-01000000187-7
ST24024203
STK628377
SW197486-3
Tocris-1611
Tox21_110179
Tox21_110179_1
Tox21_500688
TR-026049
TRI020
U3H27498KS
UNII-U3H27498KS
Z1550648755
ZINC13156
Paragraph IV (Patent) Challenges for LAMOTRIGINE
Tradename Dosage Ingredient NDA Submissiondate
LAMICTAL XR TABLET, EXTENDED RELEASE;ORAL lamotrigine 022115 2014-02-12
LAMICTAL ODT TABLET, ORALLY DISINTEGRATING;ORAL lamotrigine 022251 2009-12-21
LAMICTAL CD TABLET, CHEWABLE;ORAL lamotrigine 020764
LAMICTAL TABLET;ORAL lamotrigine 020241

US Patents and Regulatory Information for LAMOTRIGINE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Par Pharm LAMOTRIGINE lamotrigine TABLET, ORALLY DISINTEGRATING;ORAL 204158-003 Oct 27, 2015 AB RX No No   Start Trial   Start Trial   Start Trial
Cipla LAMOTRIGINE lamotrigine TABLET;ORAL 077783-004 Nov 1, 2010 AB RX No No   Start Trial   Start Trial   Start Trial
Anchen Pharms LAMOTRIGINE lamotrigine TABLET, EXTENDED RELEASE;ORAL 201374-006 Dec 26, 2012 AB RX No No   Start Trial   Start Trial   Start Trial
Amneal Pharms LAMOTRIGINE lamotrigine TABLET, EXTENDED RELEASE;ORAL 207497-003 Nov 30, 2018 AB RX No No   Start Trial   Start Trial   Start Trial
Zydus Pharms Usa LAMOTRIGINE lamotrigine TABLET;ORAL 077633-003 Jan 27, 2009 AB RX No No   Start Trial   Start Trial   Start Trial
Torrent Pharms LAMOTRIGINE lamotrigine TABLET;ORAL 078947-001 Jan 27, 2009 AB RX No No   Start Trial   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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